PMA P990030S003

Device: COSTASIS/DYNASTAT SURGICAL HEMOSTATS
Applicant: Angiotech Medical Device Technologies
PMA number: P990030
Supplement: S003
Product code: LMF
Decision date: 2002-03-14
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL OF THE UROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COSTASIS/DYNASTAT SURGICAL HEMOSTAT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO THE HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

Current openFDA PMA Record#

Device: COSTASIS/DYNASTAT SURGICAL HEMOSTATS
Applicant: Angiotech Medical Device Technologies
PMA number: P990030
Supplement: S003
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2002-03-14
Decision code: APPR
Date received: 2001-12-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL OF THE UROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COSTASIS/DYNASTAT SURGICAL HEMOSTAT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO THE HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.